FDA product code EZS: Appliance, Colostomy, Disposable
EZS is the FDA product code for appliance, colostomy, disposable. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under EZS. The average 510(k) review took 45 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Appliance, Colostomy, Disposable |
| Device class | Class I |
| Regulation | 21 CFR 876.5900 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EZS clearance
Top EZS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 1 | 1978-04-27 |
Most recent EZS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K780409 | C.R. Bard, Inc. | COLOPLAST-DURASEAL OSTOMY APPLIANCE | 1978-04-27 | 45 |
Recalls for EZS devices
openFDA lists no recalls for product code EZS.
Frequently asked questions
What is FDA product code EZS?
EZS is the FDA product code for appliance, colostomy, disposable. It is a Class I device, regulated under 21 CFR 876.5900 and reviewed by the Gastroenterology and Urology panel.
What device class is EZS?
Class I, regulation 21 CFR 876.5900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EZS?
Across 1 cleared submissions the average was 45 days from receipt to decision (median 45).
Which companies have the most EZS clearances?
C.R. Bard, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EZS
- Run a recall and safety report across every EZS manufacturer
- Watch product code EZS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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